The primary objective of this study is to test the hypothesis that administration of folate,
pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with
advanced chronic renal failure or end stage renal disease and abnormally high plasma
homocysteine levels will lower the homocysteine levels and the death rate compared to
patients who receive placebo. The secondary objective is to test the hypothesis that intake
of the vitamins compared to placebo decreases the incidence of myocardial infarction,
disabling stroke, and amputation of a lower extremity and, in hemodialysis patients,
thrombosis of the vascular access.
Phase:
Phase 3
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development
Collaborators:
Abbott Diagnostics Division Pan American Laboratories